What are the responsibilities and job description for the Development Scientist position at 3P BIOSOLUTIONS INC?
Job Title: Development Scientist – In Vitro Diagnostics (IVD)Location: Woodbridge, VAEmployment Type: Full-TimeDepartment: R&D / Product Development Position SummaryThe Development Scientist will play a key role in designing, developing, and validating IVD assays, reagents, control materials, and related consumables. This role requires strong technical expertise, hands-on laboratory experience, and a solid understanding of regulatory expectations for IVD product development. The ideal candidate is detail-oriented, collaborative, and driven by scientific excellence. Key Responsibilities- Lead or contribute to the development of IVD assays, reagents, and/or QC materials from concept through transfer to manufacturing.- Design and execute experiments following established scientific and quality procedures.- Analyze and interpret experimental data; prepare technical reports and development documentation.- Develop and optimize assay parameters, reagents, matrices, and workflows.- Support feasibility studies, verification/validation (V&V), stability studies, and risk assessments.- Collaborate with cross-functional teams including QA/RA, Manufacturing, and Product Management.- Ensure compliance with ISO 13485, FDA QSR, CLSI guidelines, and relevant regulatory requirements.- Participate in troubleshooting, root cause investigations, and continuous improvement initiatives.- Support technology transfer to production and assist with scale-up activities.- Occasional domestic travel may be needed for installations, training, or technical support for sample preparation instruments at CLIA-certified labs. Qualifications- Bachelor’s, Master’s or Ph.D. in Biology, Biochemistry, Molecular Biology, Chemistry, or related field.- 2–5 years of experience in IVD product development or clinical diagnostics industry (IVD R&D preferred).- Strong laboratory skills in immunoassay development, molecular diagnostics, chemistry-based assays, or related areas.- Experience with design of experiments (DOE), statistical analysis, and method validation.- Working knowledge of regulatory standards for IVDs (CLSI, ISO 13485, FDA, IVDR a plus).- Excellent analytical, organizational, and documentation skills.- Ability to work collaboratively in a fast-paced environment while managing multiple priorities. Preferred Experience- Experience with LC-MS/MS, ELISA, or PCR platforms.- Hands-on reagent formulation, stability studies, or lyophilization knowledge.- Experience writing technical documents for regulatory submissions. What We Offer- Competitive base salary bonus structure- Full benefits package including medical, dental, and vision insurance- 401(k) with company match- Opportunities for career development and advancement within a growing company.- Collaborative and innovative culture focused on scientific excellence.Company Description3P BioSolutions Inc. is a rapidly growing provider of advanced diagnostic and laboratory automation solutions for clinical laboratories across the United States. Our mission is to deliver unique as well as reliable solutions, responsive service, and exceptional customer support to hospital labs, reference labs, and specialty testing facilities. We are seeking a talented Development Scientist to join our growing team.
Salary : $70,000 - $90,000